U.S. FDA Approves Olysio (Simeprevir) for Hepatitis C Treatment

An article in the Science World Report stated that the US Food and Drug Administration (FDA) on November 22 approved Olysio (simeprevir), a protease inhibitor that blocked a key hepatitis C protein from multiplying and would be part of a combination therapy with peginterferon-alfa and ribavirin. The treatment would be for hepatitis-C infected adults with diseased but functioning livers; people with cirrhosis; people who had not received any hepatitis C treatment (naï¿½ve patients); and those who had received previous unsuccessful treatments.

Edward Cox, M.D., director of the Office of Antimicrobial Products in FDA's Center for Drug Evaluation and Research, noted that Olysio was the third FDA-approved protease inhibitor for chronic hepatitis C. FDA completed five clinical studies to evaluate Olysio's effectiveness and safety. The trials randomly selected participants to receive a combination of Olysio, peginterferon-alfa, and ribavirin, or to receive a combination of a placebo with peginterferon-alfa and ribavirin. After 12 weeks of treatment, 80 percent of naï¿½ve patients who received Olysio with peginterferon-alfa and ribavirin "achieved virologic response," in comparison to 50 percent of the control group. In a study of people whose hepatitis C infections returned, 79 percent of those who received Olysio with peginterferon-alfa and ribavirin achieved viral response, compared to 37 percent of the control group. Olysio was less effective with patients with genotype 1a hepatitis C virus with an NS3Q80K polymorphism, a strain common in America. Olysio's common side effects include nausea, itching, and rash. Drug instructions advised patients to avoid sun and to use sun screen during treatment.

CDC estimated in 2011 that at least 3 million US residents had hepatitis C. Although some individuals with the disease showed no symptoms for many years, long-term damage could include bleeding, jaundice, excess fluid accumulation in the stomach, and liver infection or cancer.

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